Non-Tuberculous Mycobacterial PneumoniaNCT04685720
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
A study testing LungFit in people with Non-Tuberculous Mycobacterial Pneumonia and Cystic Fibrosis, run by Beyond Air Inc. at 1 site in Australia.
Trial summary
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia
- What is being tested?
- LungFit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Dec 2020to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
- CF and Non-CF patients
Who cannot join
- Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
- History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
- Subjects with advanced cardiovascular disease or CHF
- Use of an investigational drug during the 30 days prior to enrollment.
- History of frequent epistaxis (>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
- Subject on non-constant dose of systemic steroids within 30 days prior to enrollment; subjects on constant systemic steroids if the daily dose is higher than 10 mg/d prednisolone or equivalent.
Show all 15Show fewer
- Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.
- Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
- Uncontrolled hypertension within 3 months prior to or at screening
- Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening
- Clinically significant renal or liver laboratory abnormalities
- History of daily, continuous oxygen supplementation.
- Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day 84.
- Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.
- Patient receiving drugs that have a contraindication with NO
Trial locations and contacts
1 site in 1 country.
Australia1 site
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120
About this study
Official title: A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
Read the detailed description
The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection, Mycobacterium Avium Complex
- Being tested
- LungFit
- Medical subject headings
- Cystic Fibrosis, Mycobacterium Infections, Nontuberculous, Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungFitDevice
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled NO delivered using LungFit | Experimental | Inhaled Nitric Oxide in doses up to 250 ppm Receives: Device: LungFit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent SAEs
The primary endpoint of the study is the number of patients with treatment-emergent SAEs
Measured: Day 1 to Day 84
Secondary outcomes (6)
Changes in NTM bacterial load from baseline to Day 174
Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media.
Measured: Day 1 to Day 174
Number of patients with culture conversion at Day 174
NTM culture conversion will be defined as having at least three consecutive negative NTM cultures
Measured: Day 1 to Day 174
Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module
Changes in quality of life assessed by Cystic Fibrosis Questionnaire Revised [CFQ R] for CF patients or Quality of Life Questionnaire-Bronchiectasis [QOL-B] with NTM module for non-CF patients.
Measured: Day 1 to Day 174
Changes in FEV1 from baseline to Day 174
Respiratory function will be assessed by spirometry including FEV1.
Measured: Day 1 to Day 174
Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.
Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174.
Measured: Day 1 to Day 174
Change in 6 Minute Walking Test
Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84
Measured: Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Dec 2020
- Primary completion28 Jul 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685720
- Sponsor's protocol ID
- BA_NTM_AU_01.01
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2020
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04685720
- Acronym / sponsor ID
- BA_NTM_AU_01.01
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection, Mycobacterium Avium Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
Detailed description
The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled NO delivered using LungFit | Experimental | Device: LungFitInhaled Nitric Oxide in doses up to 250 ppm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
- CF and Non-CF patients
Key exclusion criteria (15 listed)
- Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
- History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
- Subjects with advanced cardiovascular disease or CHF
- Use of an investigational drug during the 30 days prior to enrollment.
- History of frequent epistaxis (>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LungFitLungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air. | Device | Inhaled NO delivered using LungFit |
Primary outcome
Treatment-Emergent SAEs
Time frame: Day 1 to Day 84
The primary endpoint of the study is the number of patients with treatment-emergent SAEs
6 secondary outcomes
Changes in NTM bacterial load from baseline to Day 174
Time frame: Day 1 to Day 174
Number of patients with culture conversion at Day 174
Time frame: Day 1 to Day 174
Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module
Time frame: Day 1 to Day 174
Changes in FEV1 from baseline to Day 174
Time frame: Day 1 to Day 174
Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.
Time frame: Day 1 to Day 174
Change in 6 Minute Walking Test
Time frame: Day 1 to Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungFit in people with Non-Tuberculous Mycobacterial Pneumonia and Cystic Fibrosis, run by Beyond Air Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent SAEs (time frame: Day 1 to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.